Using Siltuximab to improve cognition in schizophrenia
A Randomized Controlled Trial of Adjunctive Siltuximab in Schizophrenia
This study is testing if adding Siltuximab to the usual treatment can help improve thinking skills in people with schizophrenia who have signs of inflammation.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Augusta University Academic / other |
| Drugs / interventions | Siltuximab, siltuxiumab, tocilizumab |
| Locations | 1 site (Augusta, Georgia) |
| Trial ID | NCT02796859 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety, tolerability, and efficacy of Siltuximab, an anti-IL-6 monoclonal antibody, as an adjunct treatment to antipsychotic medications in stable outpatients diagnosed with schizophrenia or schizoaffective disorder. The study involves a 9-week randomized controlled design with 30 participants who exhibit increased inflammation, as indicated by elevated levels of high-sensitivity C-reactive protein (hsCRP). Participants will receive Siltuximab via intravenous infusion, and the primary focus is to assess improvements in cognitive function compared to a placebo group. The trial aims to address the role of inflammation in schizophrenia and its impact on cognitive impairment.
Who should consider this trial
Good fit: Ideal candidates are stable outpatients with a diagnosis of schizophrenia or schizoaffective disorder who have elevated hsCRP levels and are on non-clozapine antipsychotic medications.
Not a fit: Patients who are in imminent danger to themselves or others, have a history of immune disorders, or are currently using immunomodulatory agents may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could lead to significant cognitive improvements for patients with schizophrenia, enhancing their quality of life.
How similar studies have performed: Previous studies have shown promising results with anti-inflammatory treatments in schizophrenia, suggesting that targeting inflammation could be a viable approach, although this specific method with Siltuximab is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * capable of giving informed consent * diagnosis of schizophrenia or schizoaffective disorder * stable based on clinical judgment * taking a non-clozapine antipsychotic * on the same psychotropic medications for \>4 weeks * hsCRP \>0.3 mg/dL at the screening visit Exclusion Criteria: * imminent danger to self/others * antibiotic use in the past 2 weeks * current scheduled use of immunomodulatory agents * history of an immune disorder * illicit drug use in the past 30 days * any unstable or untreated medical condition * history of gastrointestinal ulcers, diverticulitis, malignancy, CNS demyelinating disorder, seizure disorder, or exposure to tuberculosis * low absolute neutrophil (\<2000) or platelet (\<100,000) count * abnormal hepatic function (AST or ALT \>1.5 times the upper limit of normal) or renal function (BUN or creatinine \>1.5 times the upper limit of normal) * any abnormal lab test result judged to be clinically significant * active or chronic infections * pregnancy, breast feeding, or female of child-bearing potential who is not using any contraception.
Where this trial is running
Augusta, Georgia
- Augusta University — Augusta, Georgia, United States (Recruiting)
Study contacts
- Study coordinator: Brian J Miller, MD
- Email: brmiller@augusta.edu
- Phone: 706-721-4445
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.